Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-25 @ 12:49 PM
Study NCT ID:
NCT03773835
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2018-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Single IV Dose of HSK3486 Injectable Emulsion in Healthy Subjects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730813', 'term': 'HSK3486'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-01', 'studyFirstSubmitDate': '2018-12-06', 'studyFirstSubmitQcDate': '2018-12-10', 'lastUpdatePostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea', 'timeFrame': 'First dose of study drug on day 1', 'description': 'No movement of chest wall and cessation of end-tidal carbon dioxide waveform \\> 15 seconds.'}, {'measure': 'Safety by measurement of Adverse Events', 'timeFrame': 'First dose of study drug on day 1'}], 'secondaryOutcomes': [{'measure': "Modified observer's assessment of alertness/sedation（MOAA/S）", 'timeFrame': 'From first dose of study drug until fully alert on day 1', 'description': "Observe the change of modified observer's assessment of alert /sedation during the whole trial"}, {'measure': 'Bispectral index （BIS）', 'timeFrame': 'From first dose of study drug until fully alert on day 1'}, {'measure': 'Median effective dose (ED50)', 'timeFrame': 'From first dose of study drug until fully alert on day 1'}, {'measure': 'Peak concentration (Cmax)', 'timeFrame': 'From the start of administration to 48 hours after administration'}, {'measure': 'Time to plasma peak concentration(Tmax)', 'timeFrame': 'From the start of administration to 48 hours after administration'}, {'measure': 'Terminal elimination half life (t1/2z) and mean residence time (MRT)', 'timeFrame': 'From the start of administration to 48 hours after administration'}, {'measure': 'Mean residence time (MRT)', 'timeFrame': 'From the start of administration to 48 hours after administration'}, {'measure': 'Area Under the Curve (AUC0-30min, AUC0-1h, AUC0-last, and AUC0-inf)', 'timeFrame': 'From the start of administration to 48 hours after administration'}, {'measure': 'Total clearance (CL)', 'timeFrame': 'From the start of administration to 48 hours after administration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia', 'Sedation']}, 'descriptionModule': {'briefSummary': 'his single-center, open-label, uncontrolled, and dose-escalation study evaluated the safety, tolerability, and pharmacokinetics/pharmacodynamics of single IV dose of HSK3486 injectable emulsion in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy males or females with full capacity for civil conduct, between 18 and 49 years old (inclusive);\n2. Body weight \\> 45 kg, and body mass index (BMI) ≥ 19 and ≤24 kg/m2;\n3. Blood pressure between 90-140/60-90 mmHg; heart rate between 60-99 bpm; body temperature between 35.8-37.5 ºC; respiration rate between 12-24 breaths per minute; SpO2 when inhaling \\> 95%;\n4. Normal physical examination, laboratory tests (blood routine, blood biochemistry, and urine routine), 12-Led ECG, posteroanterior and lateral chest x-ray, and or abnormal but without clinical significance (determined by investigator); no potential difficult airway;\n5. Subjects must understand the procedures and methods of this study, and be willing to provide informed consent and to complete the trial in strict accordance with clinical trial protocol.\n\nExclusion Criteria:\n\n1. Known sensitivity to propofol, excipient in propofol medium and long chain fat emulsion injection, excipient in HSK3486 injectable emulsion;\n2. contraindicated in general anesthesia;\n3. Received any one of the following medications or treatments prior to screening/enrollment:\n\n 1. History of medication abuse or any signs of chronic benzodiazepines use (such as insomnia, anxiety, spasms) within 3 months prior to screening, or a positive urine medication test (during screening or at baseline);\n 2. Participated in clinical trials involving any medications or medical devices within 3 months prior to screening, or participated in 3 or more drug clinical trials within the past year;\n4. History or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, gastrodintestinal disease and other system disease prior to the screening and/or baseline period;\n5. Laboratory results that meet any of the following during screening/enrollment:\n\n 1. Positive for HBsAg, HCV, or HIV;\n 2. Abnormal hepatic or renal function confirmed after re-examination;\n\n * ALT or AST \\> ULN;\n * Creatinine \\> ULN;\n6. History of smoking for more than 3 weeks and/or respiratory irritation caused by smoking within 3 months prior to screening;\n7. History of alcohol abuse within 3 months prior to screening or a positive alcohol test (baseline);\n8. Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial;\n9. Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.'}, 'identificationModule': {'nctId': 'NCT03773835', 'briefTitle': 'A Study Evaluating Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Single IV Dose of HSK3486 Injectable Emulsion in Healthy Subjects.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Haisco Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Single-center, Open-label, Uncontrolled, and Dose-escalation Study Evaluating Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Single IV Dose of HSK3486 Injectable Emulsion in Healthy Subjects.', 'orgStudyIdInfo': {'id': 'HSK3486-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HSK3486', 'description': '0.15mg/kg, 0.40mg/kg, 0.60mg/kg, 0.90mg/kg,', 'interventionNames': ['Drug: HSK3486']}], 'interventions': [{'name': 'HSK3486', 'type': 'DRUG', 'description': 'Mmanual IV bolus injection completed in 1 minute.', 'armGroupLabels': ['HSK3486']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan Haisco Pharmaceutical Group Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}